QUEBEC CITY, Aug. 3 /CNW Telbec/ - DiagnoCure, Inc. (TSX: CUR), a life sciences company commercializing high-value cancer diagnostic tests and delivering laboratory services, announced today that the New York State Department of Health has issued a Clinical Laboratory Permit to DiagnoCure Oncology Laboratories, the Company's CLIA-approved and CAP-accredited laboratory in West Chester, Pennsylvania. The permit allows the lab to test commercial samples originating in New York for the Previstage GCC(TM) Colorectal Staging Test.
Earning the New York State Permit requires successful completion of a meticulous evaluation program that many consider to be the most rigorous in the U.S. The program includes on-site inspections, proficiency testing, and assessment of personnel qualifications to ensure the accuracy and reliability of laboratory test results. In addition, authorization to accept specimens from New York opens a significant market for Previstage(TM) GCC. According to the American Cancer Society, New York has the third highest rate of new colorectal cancer cases among U.S. states.
Valerie Palmieri, President of DiagnoCure Oncology Laboratories, commented on this achievement. "This license, coupled with the rollout of our colorectal cancer disease management program, is a considerable milestone in bringing our proprietary Previstage(TM) GCC test to colorectal specialists nationwide. Previstage(TM) GCC is the only molecular test available to help better identify whether colorectal cancer has spread to regional lymph nodes. Physicians and patients depend on this information for critical treatment decisions, and it is a top priority to implement the highest quality standards in our laboratory. We are very pleased that this commitment to quality has been recognized by New York State."
Dr. Yves Fradet, President and Chief Medical Officer of DiagnoCure, added, "I am very proud of this major accomplishment by the U.S. team. DiagnoCure Oncology Laboratories has now obtained all major U.S. clinical laboratory licenses and can receive specimens from all 50 states."
DiagnoCure (TSX: CUR) is a life sciences company commercializing high-value cancer diagnostic tests and delivering laboratory services that increase clinician and patient confidence in making critical treatment decisions. DiagnoCure Oncology Laboratories, a subsidiary of DiagnoCure, Inc., launched in 2008 the Previstage(TM) GCC Colorectal Cancer Staging Test, the first GCC-based molecular test for the management of colorectal cancer. A major study published in the February 18, 2009, edition of the Journal of the American Medical Association demonstrated that GCC, to which DiagnoCure owns exclusive worldwide diagnostic rights, is the strongest independent predictor of colorectal cancer recurrence. More clinical studies are underway to confirm the clinical utility of the Previstage(TM) GCC test. The Company has a strategic alliance with Gen-Probe (NASDAQ: GPRO) for the development and commercialization of a second-generation prostate cancer test using PCA3, DiagnoCure's proprietary molecular marker. This test is available through laboratories in the U.S. and in Canada using PCA3 analyte specific reagents (ASR) from Gen-Probe, in Europe as the CE-marked PROGENSA(R) PCA3 in vitro assay. Gen-Probe recently completed a 500-patient clinical study aimed at securing FDA approval for the commercialization of the PROGENSA(R) PCA3 test in the U.S. and is on target to file a PMA by the end of the year. For more information, visit www.diagnocure.com.
This release contains forward-looking statements that involve known and unknown risks, uncertainties and assumptions that may cause actual results to differ materially from those expected. By their very nature, forward-looking statements are based on expectations and hypotheses and also involve risks and uncertainties, known and unknown, many of which are beyond DiagnoCure's control. As a result, investors are cautioned not to place undue reliance on these forward-looking statements. The forward-looking statements regarding the outcome of research and development projects, clinical studies and future revenues are based on management expectations. In addition, the reader is referred to the applicable general risks and uncertainties described in DiagnoCure's most recent Annual Information Form under the heading "Risk Factors". DiagnoCure undertakes no obligation to publicly update or revise any forward-looking statements contained herein unless required by the applicable securities laws and regulations.
SOURCE DiagnoCure Inc.
For further information: For further information: Investors: Chantal Miklosi, Chief Financial Officer, DiagnoCure Inc., (418) 527-6100, firstname.lastname@example.org; Media: Paule De Blois, Sr. Vice President, Operations, DiagnoCure Inc., (418) 527-6100